Abstract
BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary.
OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia.
METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit.
RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it.
CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.
| Original language | English |
|---|---|
| Article number | e41532 |
| Pages (from-to) | 1-18 |
| Number of pages | 18 |
| Journal | Journal of Medical Internet Research |
| Volume | 25 |
| Early online date | 3 Feb 2023 |
| DOIs | |
| Publication status | Published - 2023 |
Bibliographical note
©Christiaan Vis, Josien Schuurmans, Bruno Aouizerate, Mette Atipei Craggs, Philip Batterham, Leah Bührmann, Alison Calear, Arlinda Cerga Pashoja, Helen Christensen, Els Dozeman, Claus Duedal Pedersen, David Daniel Ebert, Anne Etzelmueller, Naim Fanaj, Tracy L Finch, Denise Hanssen, Ulrich Hegerl, Adriaan Hoogendoorn, Kim Mathiasen, Carl May, Andia Meksi, Sevim Mustafa, Bridianne O'Dea, Caroline Oehler, Jordi Piera-Jiménez, Sebastian Potthoff, Gentiana Qirjako, Tim Rapley, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria Skjoth, Kristine Tarp, Ingrid Titzler, Erik Van der Eycken, Claire Rosalie van Genugten, Alexis Whitton, Enrico Zanalda, Jan H Smit, Heleen Riper. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.02.2023.Funding
The authors would like to thank all implementers and service providers who participated in this study. The authors would also like to thank all ImpleMentAll consortium members for their nonauthor contributions. Specifically, the authors would like to thank the local research and implementation teams, the internal Scientific Steering Committee, and the External Advisory Board for their input in designing and executing the study. Members of the ImpleMentAll consortium were Adriaan Hoogendoorn, Ainslie O’Connor, Alexis Whitton, Alison Calear, Andia Meksi, Anna Sofie Rømer, Anne Etzelmüller, Antoine Yrondi, Arlinda Cerga-Pashoja, Besnik Loshaj, Bridianne O’Dea, Bruno Aouizerate, Camilla Stryhn, Carl May, Carmen Ceinos, Caroline Oehler, Catherine Pope, Christiaan Vis, Christine Marking, Claire van Genugten, Claus Duedal Pedersen, Corinna Gumbmann, Dana Menist, David Daniel Ebert, Denise Hanssen, Elena Heber, Els Dozeman, Emilie Brysting, Emmanuel Haffen, Enrico Zanalda, Erida Nelaj, Erik Van der Eycken, Eva Fris, Fiona Shand, Gentiana Qirjako, Géraldine Visentin, Heleen Riper, Helen Christensen, Ingrid Titzler, Isabel Weber, Isabel Zbukvic, Jeroen Ruwaard, Jerome Holtzmann, Johanna Freund, Johannes H Smit, Jordi Piera-Jiménez, Josep Penya, Josephine Kreutzer, Josien Schuurmans, Judith Rosmalen, Juliane Hug, Kim Mathiasen, Kristian Kidholm, Kristine Tarp, Leah Bührmann, Linda Lisberg, Ludovic Samalin, Maite Arrillaga, Margot Fleuren, Maria Chovet, Marion Leboyer, Mette Atipei Craggs, Mette Maria Skjøth, Naim Fanaj, Nicole Cockayne, Philip J Batterham, Pia Driessen, Pierre Michel Llorca, Rhonda Wilson, Ricardo Araya, Robin Kok, Sebastian Potthoff, Sergi García Redondo, Sevim Mustafa, Søren Lange Nielsen, Tim Rapley, Tracy Finch, Ulrich Hegerl, Virginie Tsilibaris, Wissam Elhage, and Ylenia Sacco. Members of the internal Scientific Steering Committee were professor Dr Heleen Riper (chair), professor Dr David Ebert, professor Dr Kristian Kidholm, professor Dr Marion Leboyer, professor Dr Carl May, Claus Duedal Pedersen (observer), professor Dr Johannes H Smit, and professor Dr Ulrich Hegerl. Members of the External Advisory Board were Dr Bianca Albers, Mr Bruce Whitear, Mr Chris Wright, Mr Clayton Hamilton, professor Dr David Mohr, professor Dr Dean L Fixsen, professor Dr Elizabeth Murray, professor Dr Genc Burazeri, Mr Hobbe Jan Hiemstra, Mr John Crawford, professor Dr Levente Kriston, Mr Mark Bloemendaal, Dr Markus Moessner, professor Dr Nick Titov, Dr Richardo Gusmao, Mrs Simone Gynnemo, Dr Vicente Traver Salcedo, and Mrs Yammie Fishel. The authors remember Dr Jeroen Ruwaard. His death (July 16, 2019) overwhelmed the authors. Jeroen’s involvement with the study was essential, from drafting the first ideas for the grant application and writing the full proposal to providing the methodological and statistical foundations for the stepped-wedge trial design, trial data management, and ethics. Let’s get one number right was his motto, and that is what the authors did. The authors want to express their gratitude toward Jeroen for the effort he made in realizing this study. This study was funded by the European Union’s Horizon 2020 research and innovation program under grant agreement 733025 and by the National Health and Medical Research Council EU-program by the Australian Government (grant 1142363). The funding bodies had no influence on the design of the study.
| Funders | Funder number |
|---|---|
| Mrs Yammie Fishel | |
| National Health and Medical Research Council EU-program | |
| Ylenia Sacco | |
| National Health and Medical Research Council | 1142363 |
| Horizon 2020 Framework Programme | 733025 |
Keywords
- Humans
- Mental Health
- Mental Health Services
- Internet
- Surveys and Questionnaires
- Cognitive Behavioral Therapy/methods
- Treatment Outcome